How should initial fit inform soft contact lens prescribing

Purpose: To investigate how initial HEMA and silicone-hydrogel (SiHy) contact lens fit on insertion, which informs prescribing decisions, reflect end of day fit. Methods: Thirty participants (aged 22.9. ±. 4.9 years) were fitted contralaterally with HEMA and SiHy contact lenses. Corneal topography and tear break-up time were assessed pre-lens wear. Centration, lag, post-blink movement during up-gaze and push-up recovery speed were recorded after 5,10,20. min and 8. h of contact lens wear by a digital slit-lamp biomicroscope camera, along with reported comfort. Lens fit metrics were analysed using bespoke software. Results: Comfort and centration were similar with the HEMA and SiHy lenses (p > 0.05), but comfort decreased with time (p <. 0.01) whereas centration remained stable (F = 0.036, p = 0.991). Movement-on-blink and lag were greater with the HEMA than the SiHy lens (p <. 0.01), but movement-on-blink decreased with time after insertion (F = 22.423, p <. 0.001) whereas lag remained stable (F = 1.967, p = 0.129). Push-up recovery speed was similar with the HEMA and the SiHy lens 5-20. min after insertion (p > 0.05), but was slower with SiHy after 8. h wear (p = 0.016). Lens movement on blink and push-up recovery speed was predictive of the movement after 8. h of wear after 10-20. min SiHy wear, but after 5 to 20. min of HEMA lens wear. Conclusions: A HEMA or SiHy contact lens with poor movement on blink/push-up after at least 10. min after insertion should be rejected.

Fitting an MSD (Mini Scleral Design) rigid contact lens in advanced keratoconus with INTACS

Keratoconus is a bilateral degenerative disease characterized by a non-inflammatory, progressive central corneal ectasia (typically asymmetric) and decreased vision. In its early stages it may be managed with spectacles and soft contact lenses but more commonly it is managed with rigid contact lenses. In advanced stages, when contact lenses can no longer be fit, have become intolerable, or corneal damage is severe, a penetrating keratoplasty is commonly performed. Alternative surgical techniques, such as the use of intra-stromal corneal ring segments (INTACS) have been developed to try and improve the fit of rigid contact lenses in keratoconic patients and avoid penetrating keratoplasties. This case report follows through the fitting of rigid contact lenses in an advanced keratoconic cornea after an INTACS procedure and discusses clinical findings, treatment options, and the use of mini-scleral and scleral lens designs as they relate to the challenges encountered in managing such a patient. Mini-scleral and scleral lenses are relatively easy to fit, and can be of benefit to many patients, including advanced keratoconic patients, post-INTAC patients and post-penetrating keratoplasty patients. © 2011 British Contact Lens Association.

The development of biomaterials for contact lens applications:effects of wear modality on materials design

The successful design of polymers for contact lens applications depends on the ability to provide a balance of properties appropriate to the ocular environment. Principal relevant aspects of the anterior eye are the tear film, eyelid and cornea, which govern the requirements for surface properties, modulus and oxygen permeability, respectively. Permeability requirements and the developing view of the needs of the cornea, in terms of oxygen consumption and the particular roles of fluorine and silicon in the design of silicone hydrogels, which have proved to be the most successful family of materials for this demanding application, are discussed. The contact lens field is complicated by the fact that contact lenses are used in a range of wear modalities, the extremes of which can conveniently be classified as lenses that are disposed of at the end of a single period of daily wear and those used for 30. days of successive day-and-night periods, frequently referred to as extended or continuous wear. As silicone hydrogels developed, in the decade following their launch there has been a progressive trend in properties taking both modulus and water content closer to those of conventional hydrogels. This is particularly evident in the family of daily disposable contact lenses that have appeared since 2008.

Long-term efficacy of orthokeratology contact lens wear in controlling the progression of childhood myopia

Purpose: The primary outcome of this study is to compare the axial length growth of white European myopic children wearing orthokeratology contact lenses (OK) to a control group (CT) over a 7-year period. Methods: Subjects 6–12 years of age with myopia −0.75 to −4.00DS and astigmatism ≤1.00DC were prospectively allocated OK or distance single-vision spectacles (SV) correction. Measurements of axial length (Zeiss IOLMaster), corneal topography, and cycloplegic refraction were taken at 6-month intervals over a 2-year period. Subjects were invited to return to the clinic approximately 5 years later (i.e., 7 years after the beginning of the study) for assessment of their ocular refractive and biometric components. The CT consisted of 4 SV and 12 subjects who switched from SV to soft contact lens wear after the initial 2 years of SV lens wear. Changes in axial length relative to baseline over a 7-year period were compared between groups. Results: Fourteen and 16 subjects from the OK and CT groups, respectively, were examined 6.7 ± 0.5 years after the beginning of the study. Statistically significant changes in the axial length were found over time and between groups (both p <0.001), but not for the time*group interaction (p = 0.125). The change in the axial length for the OK group was 22% (p = 0.328), 42% (p = 0.007), 40% (p = 0.020), 41% (p = 0.013), and 33% (p = 0.062) lower than the CT group following 6, 12, 18, 24, and 84 months of lens wear, respectively. Conclusion: A trend toward a reduction in the rate of axial elongation of the order of 33% was found in the OK group in comparison to the CT group following 7 years of lens wear.

Visual signs and symptoms of Creutzfeldt-Jakob disease

A number of neurodegenerative diseases caused by prions have been described recently. These include Creutzfeldt-Jakob disease (CJD) in humans, scrapie in sheep and BSE in cows. Patients with CJD may suffer a range of visual problems including eye movement deficits and visual hallucinations. In addition, it is possible that CJD may be acquired via corneal transplant and that prions may be transmitted by reusable contact lenses.

A method for profiling biometric changes during disaccommodation

PURPOSE: To demonstrate the application of low-coherence reflectometry to the study of biometric changes during disaccommodation responses in human eyes after cessation of a near task and to evaluate the effect of contact lenses on low-coherence reflectometry biometric measurements. METHODS: Ocular biometric parameters of crystalline lens thickness (LT) and anterior chamber depth (ACD) were measured with the LenStar device during and immediately after a 5 D accommodative task in 10 participants. In a separate trial, accommodation responses were recorded with a Shin-Nippon WAM-5500 optometer in a subset of two participants. Biometric data were interleaved to form a profile of post-task anterior segment changes. In a further experiment, the effect of soft contact lenses on LenStar measurements was evaluated in 15 participants. RESULTS: In 10 adult participants, increased LT and reduced ACD was seen during the 5 D task. Post-task, during fixation of a 0 D target, a profile of the change in LT and ACD against time was observed. In the two participants with accommodation data (one a sufferer of nearwork-induced transient myopia and other a non-sufferer), the post-task changes in refraction compared favorably with the interleaved LenStar biometry data. The insertion of soft contact lenses did not have a significant effect on LenStar measures of ACD or LT (mean change: -0.007 mm, p = 0.265 and + 0.001 mm, p = 0.875, respectively). CONCLUSIONS: With the addition of a relatively simple stimulus modification, the LenStar instrument can be used to produce a profile of post-task changes in LT and ACD. The spatial and temporal resolution of the system is sufficient for the investigation of nearwork-induced transient myopia from a biometric viewpoint. LenStar measurements of ACD and LT remain valid after the fitting of soft contact lenses.

Development of a questionnaire to assess the relative subjective benefits of presbyopia correction

Purpose To develop a standardized questionnaire of near visual function and satisfaction to complement visual function evaluations of presbyopic corrections. Setting Eye Clinic, School of Life and Health Sciences, Aston University, Midland Eye Institute and Solihull Hospital, Birmingham, United Kingdom. Design Questionnaire development. Methods A preliminary 26-item questionnaire of previously used near visual function items was completed by patients with monofocal intraocular lenses (IOLs), multifocal IOLs, accommodating IOLs, multifocal contact lenses, or varifocal spectacles. Rasch analysis was used for item reduction, after which internal and test–retest reliabilities were determined. Construct validity was determined by correlating the resulting Near Activity Visual Questionnaire (NAVQ) scores with near visual acuity and critical print size (CPS), which was measured using the Minnesota Low Vision Reading Test chart. Discrimination ability was assessed through receiver-operating characteristic (ROC) curve analysis. Results One hundred fifty patients completed the questionnaire. Item reduction resulted in a 10-item NAVQ with excellent separation (2.92), internal consistency (Cronbach a = 0.95), and test–retest reliability (intraclass correlation coefficient = 0.72). Correlations of questionnaire scores with near visual acuity (r = 0.32) and CPS (r = 0.27) provided evidence of validity, and discrimination ability was excellent (area under ROC curve = 0.91). Conclusion Results show the NAVQ is a reliable, valid instrument that can be incorporated into the evaluation of presbyopic corrections.

Comparison of near visual acuity and reading metrics in presbyopia correction

PURPOSE: To provide a consistent standard for the evaluation of different types of presbyopic correction. SETTING: Eye Clinic, School of Life and Health Sciences, Aston University, Birmingham, United Kingdom. METHODS: Presbyopic corrections examined were accommodating intraocular lenses (IOLs), simultaneous multifocal and monovision contact lenses, and varifocal spectacles. Binocular near visual acuity measured with different optotypes (uppercase letters, lowercase letters, and words) and reading metrics assessed with the Minnesota Near Reading chart (reading acuity, critical print size [CPS], CPS reading speed) were intercorrelated (Pearson product moment correlations) and assessed for concordance (intraclass correlation coefficients [ICC]) and agreement (Bland-Altman analysis) for indication of clinical usefulness. RESULTS: Nineteen accommodating IOL cases, 40 simultaneous contact lens cases, and 38 varifocal spectacle cases were evaluated. Other than CPS reading speed, all near visual acuity and reading metrics correlated well with each other (r>0.70, P<.001). Near visual acuity measured with uppercase letters was highly concordant (ICC, 0.78) and in close agreement with lowercase letters (+/- 0.17 logMAR). Near word acuity agreed well with reading acuity (+/- 0.16 logMAR), which in turn agreed well with near visual acuity measured with uppercase letters 0.16 logMAR). Concordance (ICC, 0.18 to 0.46) and agreement (+/- 0.24 to 0.30 logMAR) of CPS with the other near metrics was moderate. CONCLUSION: Measurement of near visual ability in presbyopia should be standardized to include assessment of near visual acuity with logMAR uppercase-letter optotypes, smallest logMAR print size that maintains maximum reading speed (CPS), and reading speed. J Cataract Refract Surg 2009; 35:1401-1409 (C) 2009 ASCRS and ESCRS

New investigations into macular pigment optical density

Macular pigment (MP) is the collective name for three carotenoids, lutein, zeaxanthin and meso-zeaxanthin, which are found at high concentrations in the central macula. The macular carotenoids, like all carotenoids, are entirely of dietary origin. The term ‘macular pigment optical density’ (MPOD) refers to the peak concentration of MP in the retina, which varies from one individual to the next and is measurable in vivo. On account of its blue-light-filtering and antioxidant properties, MP has become a subject of interest with respect to age-related macular degeneration (AMD), the hypothesis being that MP helps to protect against AMD; the higher the MPOD, the lower the risk for AMD. Recently, a new MPOD-measuring device, the MPS 9000 (MPS), entered the ophthalmic market. Using this device, the research described here aimed to contribute new information to the MP literature. A second MPOD instrument, the Macular Pigment Reflectometer, was also used at times, but a reliability study (included in the thesis) demonstrated that it was unsuitable for use on its own. First, a series of exploratory investigations were undertaken to maximize the accuracy and consistency of MPOD measurements taken with the MPS; a protocol was established that substantially improved repeatability. Subsequently, a series of MPOD-based studies were conducted on anisometropia, South Asian race, blue-light-filtering contact lenses, and dietary modification with kale. The principle findings were as follows: interocular MPOD differences were not attributable to interocular refractive error differences; young adults of South Asian origin had significant gender-related MPOD differences (males>females, p<0.01), and they also had significantly higher MPOD than Caucasians (p<0.0005); wearing blue-light-filtering contact lenses for eight months did not affect MPOD; and dietary modification with kale for 16 weeks did not increase MPOD. This body of research adds new insights to MP knowledge, which in turn may contribute to MP knowledge in the context of AMD.

Influence of accommodation and refractive status on the peripheral refractive profile

AIM: The aim of the study was to determine, objectively and non-invasively, whether changes in accommodative demand modify differentially the peripheral refraction in emmetropic and myopic human eyes. METHODS: Forty subjects (19 male, 21 female) aged 20-30 years (mean 22.7 (SD 2.8) years), 21 emmetropes (mean spherical equivalent refractive error (MSE) -0.13 (SD 0.29) D) and 19 myopes (MSE -2.95 (SD 1.76) D) participated in the study. Ametropia was corrected with soft contact lenses (etafilcon A, 58% water content). Subjects viewed monocularly a stationary, high contrast (85%) Maltese cross at 0.0, 1.0, 2.0 and 3.0 D of accommodative demand and at 0, 10, 20 and 30 degrees field angle (nasal and temporal) through a +3.0 D Badal optical system. Static recordings of the accommodation response were obtained for each accommodative level, at each field angle, with an objective, open-view, infrared optometer. RESULTS: Peripheral mean spherical equivalent (M) data showed that the emmetropic cohort exhibited relative myopic shifts into the periphery, while the myopic group showed hypermetropic shifts. Increasing accommodative demand did not alter the peripheral refractive profile in either the temporal (p = 0.25) or nasal (p = 0.07) periphery with no differential accommodative effect between refractive groups in either the temporal (p = 0.77) or nasal (p = 0.73) field. Significant shifts in the J(0) astigmatic component were seen in the temporal (p<0.0005) and nasal (p<0.0005) fields with increasing eccentricity. Interaction effects between eccentricity and accommodative demand illustrated that increasing accommodative demand significantly altered the peripheral refractive profile in the temporal J(0) astigmatic component (p<0.0005). The nasal periphery, however, failed to show such an effect (p = 0.65). CONCLUSIONS: Alterations in peripheral refraction augmented by changes in ocular accommodation are relatively unaffected by refractive error for young, healthy human eyes.

Polymer-phospholipid complexes for the solubilisation and delivery of drugs to the eye

Aim: Topical application of ophthalmic drugs is very inefficient; contact lenses used as drug delivery devices could minimize the drug loss and side effects. Styrene-maleic acid copolymers (PSMA) can form polymer-phospholipid complexes with dipalmitoyl phosphatidylcholine (DMPC) in the form of nanometric vesicles, which can easily solubilise hydrophobic drugs. They can be dispersed on very thin contact lens coatings to immobilize the drug on their surface. Methods: Two types of complexes stable at different pH values (5 and 7 respectively) where synthesized and loaded with drugs of different hydrophilicities during their formation process. The drug release was studied in vitro and compared to the free drug. Results: The mean sizes of the complexes obtained by light scattering were 50 nm and 450 nm respectively with low polydispersities. However, they were affected by the drugs load and release. An increase was observed in the duration of the release in the case of hydrophobic drugs, from days to weeks, avoiding initial “burst” and with a lesser amount of total drug released due to the interaction of the drug with the phospholipid core. The size and charge of the different drugs and the complexes nature also affected the release profile. Conclusions: Polymer-phospholipid complexes in the form of nanoparticles can be used to solubilise and release hydrophobic drugs in a controlled way. The drug load and release can be optimised to reach therapeutic values in the eye.

Cellular interaction with novel biomaterials

The objective of this thesis is to report the behaviour of mammalian cells with biocompatible synthetic polymers with potential for applications to the human body. Composite hydrogel materials were tested as possible keratoprosthetic devices. It was found that surface topography is an important consideration, pores, channels and fibres exposed on the surface of the hydrogels tested can have significant effects on the extent of cell adheson and proliferation. It is recommended that the core component is fabricated out of one of the following to provide a non cell adhesive base; A8, A11, A13, A22, A23. The haptic periphery fabricated out of one of the following would provide a cell adhesive composite; A16, A30, A33, A37, A38, A42, A43, A44. The presence of vitronectin in the ocular tissue appears to lead to higher cell adhesion to the posterior surface of a contact lens when compared to the anterior surface. Group IV contact lenses adhere more cells than Group II contact lenses - this may indicate that more protein (including vitronectin) is able to adhere to the contact lens due to the Group IV contact lenses high water content and ionic hydrogel matrix. Artificial lung surfactant analogues were found to be non cytotoxic but also decreased cell proliferation when tested at higher concentrations. Poly(lysine ethyl ester adipamide) [PLETESA] had the most favourable response on cell proliferation and commercial styrene/maleic anhydride (pMA/STY sp2) the most pronounced inhibitory response. The mode of action that decreases cell proliferation appears to be through membrane destabilization. Tissue culture well plates coated with PLETESA allowed cells to adhere in a concentration dependent manner, multilaminar liposomes possibly of PLETESA were observed in solution in PLETESA coated wells. Polyhydroxybutryate (PHB) and polyhydroxyvalerate (PHV) blends that contained hydroxyapatite were found to be the most cell adhesive material of those materials tested. The blends that were most susceptible to degradation adhered the most cells in initial stages of degradation. The initial slight increase in cell adhesion may be due to the increased rugosity of the material. As the degradation continued the number of cells adhering to the samples decreased, this may indicate that the polarity was inhibitory to cell adhesion during the later stages of degradation.

Immunological and biochemical techniques in the analysis of tear proteins

This study is concerned with the analysis of tear proteins, paying particular attention to the state of the tears (e.g. non-stimulated, reflex, closed), created during sampling, and to assess their interactions with hydrogel contact lenses. The work has involved the use of a variety of biochemical and immunological analytical techniques for the measurement of proteins, (a), in tears, (b), on the contact lens, and (c), in the eluate of extracted lenses. Although a diverse range of tear components may contribute to contact lens spoilation, proteins were of particular interest in this study because of their theoretical potential for producing immunological reactions. Although normal host proteins in their natural state are generally not treated as dangerous or non-self, those which undergo denaturation or suffer a conformational change may provoke an excessive and unnecessary immune response. A novel on-lens cell based assay has been developed and exploited in order to study the role of the ubiquitous cell adhesion glycoprotein, vitronectin, in tears and contact lens wear under various parameters. Vitronectin, whose levels are known to increase in the closed eye environment and shown here to increase during contact lens wear, is an important immunoregulatory protein and may be a prominent marker of inflammatory activity. Immunodiffusion assays were developed and optimised for use in tear analysis, and in a series of subsequent studies used for example in the measurement of albumin, lactoferrin, IgA and IgG. The immunodiffusion assays were then applied in the estimation of the closed eye environment; an environment which has been described as sustaining a state of sub-clinical inflammation. The role and presence of a lesser understood and investigated protein, kininogen, was also estimated, in particular, in relation to contact lens wear. Difficulties arise when attempting to extract proteins from the contact lens in order to examine the individual nature of the proteins involved. These problems were partly alleviated with the use of the on-lens cell assay and a UV spectrophotometry assay, which can analyse the lens surface and bulk respectively, the latter yielding only total protein values. Various lens extraction methods were investigated to remove protein from the lens and the most efficient was employed in the analysis of lens extracts. Counter immunoelectrophoresis, an immunodiffusion assay, was then applied to the analysis of albumin, lactoferrin, IgA and IgG in the resultant eluates.

Synthesis and characterisation of hydrogel polymers for medical applications

A fundamental if poorly understood problem that hydrogels display is the tendency of these contact lens materials to dehydrate, causing certain complications of the corneal epithelium. However, recent studies have indicated that the evaporation rate of water from different hydrogel lenses is the same and the severity of conditions such as corneal staining is controlled by the states of water in the material. A study was therefore undertaken which concluded that increased corneal desiccating staining occurred as the proportion of water existing in the bound state decreased. The possibility of using dehydrated hydrogels as packaging materials with desiccating properties has also been investigated. As hydrogels have a high affinity for water they have adequate ability to function as a moisture scavenger in an enclosed atmosphere. It was concluded that this ability is maximised by a high total water content and an increase in the proportion of this water existing in the bound state for the material when it is fully hydrated. N-vinyl pyrrolidone has a low reactivity in vinyl polymerisation reactions which results in polymers with local domains of the same chemical type which can lead to deposition. As contact lenses comprising of this monomer are susceptible to deposition, a monomer with a higher reactivity in vinyl polymerisations is acryloylmorpholine and its incorporation in favour of NVP is encouraged. Unfortunately a large proportion of high EWC hydrogels are mechanically weak and attempts to increase this property by increasing hydrophobicity or cross-linking results in a decrease in EWC. Monomers with the potential to carry a positive charge were incorporated into a high EWC, AMO-HEMA copolymer and the physical properties were investigated. Although EWC increased, mechanical properties decreased only slightly. Therefore simultaneous incorporation of a positively charged monomer and a negatively charged monomer was investigated. The resulting copolymers showed increased water content and increased initial modulus. A technique for measuring the coefficient of friction of contact lenses during lubrication has been developed.

Ocular biomaterials and the anterior eye

Hydrogels, water swollen polymer matrices, have been utilised in many biomedical applications, as there is the potential to manipulate the properties for a given application by changing the chemical structure of the constituent monomers The eye provides an excellent site to examne the interaction between a synthetic material and a complex biological fluid without invasive surgery. There is a need for the development of new synthetic hydrogels for use in the anterior eye, Three applications of hydrogels in the eye were considered in this thesis. For some patients, the only hope of any visual improvement lies in the use of an artificial cornea, or keratoprosthesis, Preliminary investigations of a series of simple homogeneous hydrogel copolymers revealed that the mechanical properties required to withstand surgery and in eye stresses, were not achieved This lead to work on the development of semi-interpenetrating polymer networks based on the aforementioned copolymers, Manufacture of the device and cell response were also studied. Lasers have been employed in ocular surgery to correct refractive defects. If an irregular surface is ablated, an irregular surface is obtained. A hydrogel system was investigated that could be applied to the eye prior to ablation to create a smooth surface. Factors that may influence ablation rate were explored, Soft contact lenses can be used as a probe to study the interaction between synthetic materials and the biological constituents of tears. This has lead to the development of many sensitive analytical techniques for protein and lipid deposition, one of which is fluorescence spectrophotometry. Various commercially available soft contact lenses were worn for different periods of time and then analysed for protein and lipid deposition using fluorescence spectrophotometry, The influence of water content, degree of ionicity and the lens material on the level and type of deposition was investigated.